DevicePMAs@therightstef:P960013_S018 JSONTXT 11 Projects

Approval to modify the lead insulation on the tendril st 1788t/tc and tendril st 1782 leads, and to reduce the outer coil wire diameter on the tendril st 1782 lead. The devices, as modified, will be marketed under the trade names tendril st lead model 1888tc and tendril st lead model 1882tc. The tendril st lead model 1888tc is indicated for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible pulse generator. The tendril st lead model 1882tc is indicated for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible pulse generator.